On December 17, 2018 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported that it has terminated the previously-announced merger agreement with NovellusDx, effective immediately (Press release, Cancer Genetics, DEC 17, 2018, View Source [SID1234532102]).

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As a result of the termination of the merger agreement, the Company will pursue alternative strategic and financial transactions with the goal of enhancing shareholder value. The Company will again work with Raymond James & Associates, Inc. as a financial advisor in its evaluation of a broad range of financial and strategic alternatives, including additional capital raising transactions, the acquisition of another company or complementary assets or the potential sale or merger of the Company or another type of strategic partnership.

John A. Roberts, Chief Executive Officer of Cancer Genetics, commented, "Based on difficulties we have had in advancing the merger process, as well as certain other factors, we believed it was in the best interests of Cancer Genetics and our shareholders to terminate the merger agreement with NovellusDx. Notwithstanding these challenges, we continue to make progress in our core business. Over the course of 2018, and in the third quarter in particular, we have continued to make substantive advancements toward streamlining our operations, creating more focus in our strategy and positioning the Company to grow revenues through the expansion of our biopharma business while maintaining strict control over our expenses. We have strengthened our management team, continue to improve our lab processes and formed strategic partnerships that are expected to contribute new streams of revenue to drive our long-term growth. We believe that we are on track to deliver solid operational performance in the fourth quarter of 2018 and remain confident in the strength of our core business, the continued dedication of our talented professional staff, and the strong relationships we have with our biopharma customers. We will continue to work with Raymond James to evaluate new potential strategic and financial alternatives aimed at enhancing shareholder value, are optimistic about our future and look forward to providing further updates on this process. "

On December 17, 2018 Kineta Immuno-Oncology, LLC (KIO), a subsidiary of Kineta, Inc., reported that it has entered into a strategic research collaboration with Pfizer Inc. (NYSE: PFE) to develop RIG-I agonist immunotherapies for the treatment of cancer (Press release, Kineta, DEC 17, 2018, View Source [SID1234532100]). The research collaboration and license agreement grants to Pfizer the exclusive rights to KIO’s RIG-I screening platform and related compounds and technologies. The companies will collaborate to develop and test small molecule agonists that target RIG-I, an innate immunostimulatory pathway that can elicit immunogenic cell death (ICD) in tumors, providing both direct tumor cell killing and enhanced anti-tumor immune responses.

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In preclinical models, Kineta’s RIG-I agonists have demonstrated complete tumor regression and an increase in tumor-specific T cells when given as a monotherapy. Additionally, the compounds have demonstrated synergistic effects when used in combination with other immunotherapies like checkpoint inhibitors. Kineta’s proprietary approach is part of an internally developed discovery program focused on innate immune drug targets in cancer. The lead program is focused on the RIG-I pathway, which is differentiated from other innate immune-targeted immunotherapies as its compounds are small molecule drugs with the potential for oral and systemic administration.

"This alliance will enable Kineta and Pfizer to leverage each company’s expertise to accelerate the development of our RIG-I immuno-oncology program," said Kineta CEO, Shawn Iadonato. "Pfizer is an excellent partner for Kineta’s technology, with a strong commitment to oncology and outstanding development capabilities. We are very enthusiastic about this new cancer immunotherapy collaboration, which represents the second major partnering transaction for Kineta this year."

Dr. Robert Abraham, Senior Vice President and Group Head of Pfizer’s Oncology Research & Development Group said: "Therapies that trigger activation of the innate immune response in tumors have significant potential to expand the number of patients who will benefit from cancer immunotherapy, especially if they can be administered systemically. Kineta has taken a promising, differentiated approach to the discovery of RIG-I agonists, and we are looking forward to collaborating with Kineta and jointly developing these RIG-I-targeted agents into medicines with potentially unique immune-stimulating properties."

Under the terms of the agreement, KIO will receive a $15 million upfront payment and will be eligible to receive up to $505 million in potential research, development and sales milestone payments. Additionally, KIO is eligible to receive tiered royalties on net sales. Pfizer will fund RIG-I target-related research conducted by Kineta for an initial period of three years, after which Pfizer will be responsible for further development and commercialization of product candidates.

Torreya acted as exclusive financial advisor to Kineta on this transaction.

On December 17, 2018 Abbott (NYSE: ABT) reported that it will announce its fourth-quarter 2018 financial results on Wednesday, Jan. 23, 2019, before the market opens (Press release, Abbott, DEC 17, 2018, View Source [SID1234532099]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On December 17, 2018 Bristol-Myers Squibb Company (NYSE:BMY), and Boston Medical Center, a private, not-for-profit, academic medical center, reported a multi-year joint research study to identify and analyze potential sensitivity and resistance markers in patients treated with standard-of-care checkpoint inhibitors (Press release, Bristol-Myers Squibb, DEC 17, 2018, View Source [SID1234532098]). The comprehensive, multi-dimensional study will place an emphasis on uncovering mechanisms associated with lack of response to Immuno-Oncology (I-O) therapies, with the ultimate goal of identifying prognostic and potentially predictive I-O biomarkers in a variety of cancers.

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"Our newly opened R&D site in Kendall Square is focused on better understanding, and ultimately overcoming, the challenge of I-O resistance. We are thrilled to establish our first partnership since the site opened with our new neighbor, Boston Medical Center, with the goal of uncovering new insights into the biology of cancer and how it evolves with exposure to I-O intervention," said Saurabh Saha, M.D., Ph.D., senior vice president and global head of translational medicine, Bristol-Myers Squibb. "The information we glean from this collaboration will ultimately inform the development of novel therapeutic strategies to improve response rates and outcomes for patients."

Through the study, researchers will explore the role of tissue and circulating biomarkers on treatment sensitivity and resistance. In addition, scientists will investigate the role of the microbiome as a potential predictive biomarker in patients receiving treatment with immune checkpoint inhibitors.

"Boston Medical Center serves a diverse patient population, with 70 percent of our patients coming from underserved communities," said Matthew Kulke, M.D., chief of hematology/oncology at Boston Medical Center. "These patients are sorely underrepresented in current research studies. We look forward to partnering with Bristol-Myers Squibb on this study to identify and assess biomarkers across a diverse patient population, providing us with a deeper and more comprehensive understanding of I-O resistance."

The two organizations will jointly conduct the research throughout the duration of the study, after which Bristol-Myers Squibb and Boston Medical Center may collaborate to publish results.

Bristol-Myers Squibb opened its Cambridge R&D site, located in Kendall Square, on November 26, 2018.

On December 17, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported top line results from the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease (Press release, Puma Biotechnology, DEC 17, 2018, View Source [SID1234532097]). The Phase III NALA trial is a randomized controlled trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer. The trial enrolled 621 patients who were randomized (1:1) to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The co-primary endpoints of the trial are centrally confirmed progression free survival (PFS) and overall survival (OS). An alpha level of 1% was allocated to the PFS and 4% allocated to OS. The study was to be considered positive if either of the co-primary endpoints was positive. Puma reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial.

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For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (p=0.0059) compared to treatment with lapatinib plus capecitabine. For the primary analyses of OS, neratinib plus capecitabine resulted in an improvement in OS that did not achieve statistical significance but trended positively in favor of the neratinib plus capecitabine arm of the study (p=0.21). For the secondary endpoint of time to intervention for symptomatic central nervous system disease (also referred to as brain metastases), the results of the trial showed that treatment with neratinib plus capecitabine led to an improvement over the combination of lapatinib plus capecitabine (p=0.043).

The safety profile of neratinib in the Phase III NALA study was consistent with previous clinical trials of neratinib.

Full results of the trial will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency. Results of the trial will be submitted for presentation at a major medical conference in 2019.

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are highly encouraged by these results from the NALA trial with the combination of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments. We look forward to working with the regulatory authorities in the hope of bringing another potential treatment option to patients with HER2-positive metastatic breast cancer as soon as possible."

Conference Call

Puma Biotechnology will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Monday, December 17, 2018, to discuss the results of its NALA trial. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 30 days.